RU2633322C2 - System and method of hybrid surface radiotherapy with ultrasound control - Google Patents

Abstract

FIELD: physics.

SUBSTANCE: system for radiation treatment of affected skin areas contains a small-sized mobile basic module containing at least one processor for performing data collection and processing operations used during planning and delivery of radiation treatment, a high-frequency ultrasound image forming device connected to the main module via a wire, which is designed to scan and collect image data relating to the anatomy and topology of the patient's skin, and to supply image data to at least one processor, wherein the high-frequency ultrasonic device designed to operate at an ultrasonic frequency in the range from 20 to 70 MHz to produce images of the affected area, present within at least one of the skin layers selected from the group consisting of epidermis, deris and subdermis. Processor is configured to execute instructions saved in a memory unit, for performing operations including reception of a plurality of two-dimensional image layers from high frequency ultrasonic imaging device, wherein each image layer passes through the specified plurality of skin layers, separation of the affected area inside the skin layers, which includes edges of the affected area, in each of the plurality of two-dimensional image layers to obtain a plurality of processed image layers, integration of at least a part of the plurality of two-dimensional image processed layers to form a three-dimensional model of the affected area, which includes parts under the affected area surface and edges under the affected area surface inside the plurality of skin layers, analysis of the three-dimensional model of the affected area inside the plurality of skin layers to determine affection type, affected area dimension, affected area edges and affected area depth, determination of therapeutic dosimetry, wherein parameters of the therapeutic dosimetry include energy level, dose location and three-dimensional dose boundaries set inside the plurality of skin layers, a radiotherapeutic device mounted on a small-sized mobile main module, comprising a therapeutic bar and a therapeutic head, wherein the therapeutic bar is made swivel, at least one positioning system, configured to obtain positional data and adjust the therapeutic head in accordance with the dose location and the three-dimensional dose boundaries for the affected area. The system is equipped with a device readable by a computer. The method for treating the affected skin area involves the use of the system.

EFFECT: expansion of the range of technical means for radiotherapy with ultrasound control.

20 cl, 11 dwg

Description

CROSS RELATIONS TO RELATED APPLICATIONS

[0001] This application claims priority to provisional patent application US No. 61/586,030 dated 12/01/2012, which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates to systems, devices and methods for detecting and treating skin pathologies, such as skin cancer; in particular, it relates to ultrasound detection of skin cancer and its treatment with surface radiotherapy.

BACKGROUND

[0003] Skin cancer is an abnormal growth of skin cells and is the most commonly diagnosed type of cancer. The three most common malignant types of skin cancer are basal cell skin cancer, squamous skin cancer, and melanoma, each of which is named after the type of skin cell in which it occurs. The chances of successfully surviving skin cancer increase if it is detected in the early stages, and proper treatment has been carried out. The present invention relates to advanced means of detection and treatment.

SUMMARY OF THE INVENTION

[0004] The claimed system and method provides an integrated platform for surface radiotherapy with visual control, which can be implemented as a single integrated system with specialized and targeted sequences of actions and controls. The imaging component is provided by imaging by high frequency ultrasound. A radiotherapeutic device with integrated components provides the user with the opportunity to obtain characteristics, measurements and accurate determination in time of the profile of the radiation beam in real time to ensure the accuracy of the radiation beam and its reproducibility. The specified system and method optimizes the treatment procedure, provides better results for patients, doctors and the healthcare system due to more accurate application of therapy, timely intervals for the use of therapy, reduction or even elimination of the need for invasive biopsy and recovery procedures.

[0005] In one embodiment of the invention, a system for radiotherapy treatment is provided. The system may comprise a high frequency ultrasound imaging device for the affected area. The system may also include a processor that executes instructions stored in the storage device for performing operations, said operations may include receiving a plurality of images of the affected area from a high-frequency ultrasound imaging device, constructing (“rendering”) a three-dimensional model of the affected area using the specified set images from a high-frequency ultrasonic imaging device, and the determination of therapeutic dosimetry based This three-dimensional model of the affected area. The system may also comprise a radiotherapeutic device for providing radiotherapeutic treatment of the affected area, where the radiotherapy treatment is based on said therapeutic dosimetry. The system may also include a movable main module, in which at least partially enclosed a high-frequency ultrasonic imaging device, a processor that executes instructions stored in the storage device for performing operations, and a radiotherapy device.

[0006] In one configuration, the system may comprise a articulated therapeutic rod mounted on a movable main module for positioning a radiotherapy device for targeting radiation. The system may also include a camera equipped with the indicated hinge rod, a laser pointer equipped with a radiotherapeutic device, wherein said camera and laser pointer form a video laser positioning system.

[0007] In another embodiment of the invention, the system may also comprise an array of solid state x-ray detectors inside a radiotherapy device for reading characteristics of the radiation emitted by said x-ray tube. Further, further operations of the system may include testing the radiotherapy device using an array of solid state x-ray detectors, determining the characteristics of the radiation emitted by the specified x-ray tube based on said testing of the radiotherapy device, and adjusting the radiotherapy device based on the characteristics of the radiation emitted by the x-ray tube.

[0008] In another embodiment of the invention, a system for radiotherapy treatment may include a memory device that stores instructions, and a processor that executes these instructions for performing operations. These operations may include receiving multiple images of the affected area from a high-frequency ultrasound imaging device, constructing a three-dimensional model of the affected area using the specified set of images from a high-frequency ultrasonic imaging device, determining therapeutic dosimetry based on this three-dimensional model of the affected area, and providing therapeutic dosimetry for use with radiotherapeutic device. System operations may also include receiving test data from a radiotherapy device using an array of solid state x-ray detectors and characterizing the radiation emitted by the x-ray tube based on said testing of the radiotherapy device. The operations may also include adjusting the radiotherapy device based on the characteristics of the radiation emitted by the x-ray tube.

[0009] In one configuration, system operations may also include constructing a plurality of two-dimensional cross-sectional images of the affected area. Additionally, system operations may include determining the edge of the affected area and determining the volume of this affected area. Additionally, system operations may include determining a therapeutic voxel corresponding to the volume of the affected area to be treated.

[0010] In another embodiment, a computer-readable device contains instructions that, when executed by a processor, may cause the processor to perform operations. These operations may include receiving multiple images of the affected area from a high-frequency ultrasound imaging device, constructing a three-dimensional model of the affected area using the specified set of images from a high-frequency ultrasonic imaging device, determining therapeutic dosimetry based on this three-dimensional model of the affected area, and providing therapeutic dosimetry for use with radiotherapeutic device. The operations may also include receiving test data of the radiotherapy device using an array of solid state x-ray detectors and characterizing the radiation emitted by the x-ray tube based on said testing of the radiotherapy device. Additionally, these options may include adjusting the radiotherapy device based on the characteristics of the radiation emitted by the x-ray tube, and constructing a plurality of two-dimensional cross-sectional images of the affected area. In addition, operations may include determining the edge of the affected area, determining the volume of this affected area and determining a therapeutic voxel corresponding to the volume of the affected area to be treated.

[0011] In yet another embodiment of the invention, there is provided a method for treating affected areas, which may include obtaining a plurality of images of the affected area using a high-frequency ultrasound device, processing by applying instructions stored in the memory and executed by the processor, the specified set of images of the affected areas obtained from using a high-frequency ultrasound device, analysis of the processed set of images of the affected area and providing the determination of the target radiotherapeutic effect on the focus of the pathology based on the analysis of the processed many images of the affected area. The method may also include obtaining a plurality of images of the affected area after radiotherapy treatment with a high-frequency ultrasound device after providing the targeted radiotherapeutic effect on the affected area and during the treatment period and providing further targeted radiotherapeutic effect on this affected area based on the specified set of images of the affected area after the radiotherapy treatment.

[0012] In another configuration, providing a targeted radiotherapeutic effect on the affected area based on an analysis of the processed multiple images of this affected area may include multiple sessions of providing the targeted radiotherapeutic effect on the affected area during the treatment period. The method may also include analyzing the topography of the affected area periodically during the treatment period. The method may further include analyzing the volume of the affected area periodically during the treatment period and determining a therapeutic voxel corresponding to the volume of the affected area to be treated.

[0013] In one embodiment, the radiotherapy device may comprise an x-ray tube body that emits radiation, a retractable support structure provided in the x-ray tube housing, the retractable support structure configured to move between the x-ray test position and the non-test position, and a matrix an X-ray imaging detector coupled to the retractable support structure, wherein the matrix detector is IAOD X-ray images at the position of X-ray testing reads the characteristics of the radiation emitted by the X-ray tube. In one configuration, said array detector may be an array of solid state x-ray detectors. The characteristics of the radiation emitted by the x-ray tube may indicate a misalignment of the x-ray tube or its window. Additionally, the radiotherapeutic device may include a storage device that stores instructions and a processor that executes the instructions for performing operations, and these operations may include analyzing the integrity of the shape of the radiation beam emitted by the x-ray tube, and determining the shape of the radiation beam emitted by the x-ray tube.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] FIG. 1 shows an image, with a high degree of schematic, of the components of this system used in the methods described herein.

[0015] FIG. 2 shows an exemplary embodiment of a radiotherapy system with visual control.

[0016] FIG. 3 is a schematic drawing of another embodiment.

the implementation of a radiotherapy system with visual control.

[0017] FIG. 4A is a flowchart of imaging and tumor quantification.

[0018] FIG. 4B is a dosage table for radiotherapy.

[0019] FIG. 5 is a flowchart of a method for diagnosis and treatment.

[0020] FIG. 6 illustrates an exemplary embodiment of a beam-reading component.

[0021] FIG. 7 is a flowchart of a patient treatment process.

[0022] FIG. 8A and 8B show exemplary image forming results.

[0023] FIG. 9 is a schematic representation of a machine in the form of a computer system in which a set of instructions, when executed, can lead the machine to implement any of at least one of the techniques discussed herein.

DETAILED DESCRIPTION OF THE INVENTION

[0024] As shown in the drawings, the system can provide both diagnostic and therapeutic functioning with a single platform and an integrated sequence of actions for better service and benefit to a practitioner and patient with skin cancer and / or affected areas of the skin. The system includes an imaging device and a radiotherapy device, shared for diagnosis, treatment and treatment verification. Thus, this system may be a hybrid system for surface radiotherapy treatment with visual control. The system contains software for analyzing data and images produced by the image forming apparatus to provide targeted and focused treatment using a radiotherapy device. Additionally, if necessary, diagnostic protocols can be repeated during the treatment process to adjust, focus, increase or decrease radiotherapy.

[0025] FIG. 1 depicts a high-level view of a system 150 and its four main submodules. The system may comprise a radiotherapy component 101 with an X-ray tube 100, a solid-state X-ray beam reading component 102, an ultrasound component 103 with a transducer 104, a system control component 105 for controlling radiotherapy of the radiotherapy component 101 based on images and data received from the ultrasonic component 103 and the transducer 104. System control component 105 can also work with solid-state beam-reading component 102 to ensure that radiotherapy carried out with proper intensity, depth and size.

[0026] The ultrasound component 103 may include an electronic control circuit, system drivers, operation management software, and a transducer 104, which may be a high frequency ultrasound transducer, to form anatomical images of the surface epidermis, skin, and / or subcutaneous tissue. The ultrasonic component 103 interacts with the system control software component 105 through the bus and system drivers.

[0027] The radiotherapeutic component 101, which may be a component for surface radiotherapy, and the x-ray tube 100 together may comprise an electronic control circuit, at least one cooling element for the x-ray tube, power sources, at least one high voltage generator, at least one replaceable store of aluminum (Al) filters, at least one collimating applicator and at least one hardware time counter, which works in conjunction with a software time counter for duplication of functions and other purposes.

[0028] The solid state x-ray beam reading component 102 can track the output beam of the radiotherapy component 101 and the x-ray tube 101, as well as the overall stability and performance of the system. The solid-state x-ray-reading beam component 102 is mounted under the x-ray tube 100 and is displaced in front of the indicated tube when the system 150 needs to be tested for quality control or to diagnose the entire system 150. Otherwise, it returns to its original position at a distance from the x-ray tube 100 and the x-ray beam so that it does not interfere with normal operation.

[0029] In operation, system 150 uses a high frequency ultrasound component 103 with transducer 104 to scan and image affected areas containing basal cells (BCC) and flat cells (SCC). After the affected areas are scanned and their image is formed by the system 150, the data is processed using the system software. The system software can analyze and quantify the tumor and subsequently prepare a treatment plan arising from the actual parameters of the tumor, such as volume, contour length, penetration depth and tissue density. Once the analysis and quantification of the tumor is completed, the software of the system 150 provides analytical control to provide the most accurate and appropriate surface radiotherapy for the scanned and analyzed tumor. Then, the indicated therapy is carried out by means of the integrated surface radiotherapeutic component 101. The system software documents the complete diagnostic and treatment cycle, and also archives the patient data in the patient data storage 107 and the function log of the entire system 150 in the system data storage 108.

[0030] The surface radiotherapy component 101 can be used to treat any tumors, affected areas, or areas where analysis or diagnosis indicates that treatment is required. Surface radiotherapy component 101 delivers collimated and focused x-ray photons to treatment areas. Treatment can be carried out without any biopsy and pre-treatment tests, tests during treatment and after treatment can be performed locally without the need for remote sources or tests. The level of treatment can be determined as follows.

[0031] The system 150 is controlled and powered by a system control component 105, which may include a central computer with a system board that runs the operating and control software using various parallel and connected boards that allow it to control, interact and monitor various subcomponents and modules of system 150. This ensures a harmonious functional relationship between the two main clinical components of system 150, component 101 of the surface oh radiotherapy, which provides a radiotherapy treatment, and the ultrasonic component 103 which is used to scan and collect data about the anatomy of interest to the patient's skin and topology for further analysis, diagnosis, quantification and therapy planning. The system control component 105 may be connected to data stores, including a patient data store 107 and a system data store 108. System 150 may also be connected to a network 106, such as a local area network, wide area network, and / or Internet, which enables the exchange of clinical and system data with remote systems or networks.

[0032] The patient data storage 107 and the system data storage 108 may be solid state drives, hard disk drives, or other storage devices. Patient data storage 107 may store patient data and treatment parameters, such as medical history, treatment history, and photographs and documentation of the disease. System data storage 108 stores all system-related data and parameters, such as a system log, x-ray calibration data, and system diagnostic results. The patient data storage 107 and the system data storage 108 may be separate devices, or may be physically combined. In the case where the repositories 107 and 108 are combined as one repository, at least one partition may be used.

[0033] One embodiment of a radiotherapy treatment and diagnostic system 250 under ultrasound guidance is shown in FIG. 2. System 250 may comprise a main module 201 with various components mounted on or connected to it. These components may comprise a radiotherapeutic treatment device 220 and its various components, as well as an ultrasound imaging device.

[0034] The main module 201 is usually a small module, such as a module with a 30ʹʹ × 30ʹʹ base and, for ease of maneuvering, can be mounted on rollers 210. The main module 201 may include a power cable for optionally providing power for all components enclosed in the main module 201 or connected to it. In this case, the main module 201 may comprise at least one computer for controlling the components of the system 250 and / or analyzing and processing the data received from the components of the system 250. A monitor 200 may also be mounted on the main module 201 as a user interface. Similarly, a terminal or input device 214, such as a keyboard or mouse, is included.

[0035] For mounting the radiotherapeutic treatment device 220 on the main module 210, a mounting support 202 is provided. The radiotherapeutic treatment device 202 may include a therapeutic rod 203 and a therapeutic head 206, which may include removable or movable applicators 207, 208. The therapeutic rod 203 is rotated with using sliding articulated joints 209. To ensure remote operation or document treatment, a camera 216 may also be included. A video laser position system may be formed positioning, containing a camera 215 and a laser or laser pointer 217, which visually marks the area using a crosshair, which will receive radiotherapy treatment. The camera 215 can capture low transparency images of the therapeutic head 206 for radiotherapy and the crosshair of the laser pointer 217 during treatment so that accurate positioning and orientation can be reproduced during subsequent treatments. Meanwhile, the video laser positioning system can identify the correct and accurate positioning and orientation of the therapeutic head 206. The video laser positioning system can also provide remote control and operation of the therapeutic rod 203 so that the therapeutic head 206 can be accurately positioned, although the user is remote. When operating as described below, the therapeutic rod 203 can be rotated and positioned so as to allow the therapeutic head to apply radiotherapy to the patient.

[0036] The ultrasound device 230 may include an ultrasound head 205 attached through a wire 204 to the main module 201 and machines for collecting and processing data contained therein. In use, the ultrasound device 230 can be used to collect images and diagnostic data or the treatment area before treatment, during and after it. In some configurations, the ultrasound head 205 may be mounted on the rod 203 instead of being positioned separately.

[0037] The wire 211 can connect the system 250 to another computer or use an interface that can be located behind the screen 213 to remotely operate the system 250 or components of the system 250, such as a radiotherapy treatment device 220.

[0038] FIG. 3 shows a schematic view of various components and subcomponents of a system 350. System 350 may include a bus 310 through which various components can communicate with each other and / or processor 330 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), or both) . Processor 330 may be coupled to bus 310, as shown in FIG. 3 or combined with it. Power supplies 301, 302, 303 may also be provided.

[0039] The system 150 is controlled and powered by a processor 330, which runs the system 350 software or instructions 332, which control the functions of the system 350, check security mechanisms, and service and calibration functions. The processor may communicate with a computer-readable medium 334, which may be a static storage device 336 that stores at least one set of instructions 332 (eg, software) that embodies at least one technique or function described herein and comprising methods described herein. Instructions 332 may also reside, in whole or at least partially, in system data storage 304, static memory, or in processor 330, or a combination thereof, during execution by system 350. System data storage and patient data storage and processor 330 are also may be computer readable media.

[0040] The processor 330 may communicate with a motherboard having the proper amount of static or dynamic RAM, such as 4 GB of dynamic RAM, in order to optimally support and maintain the operating system, main software, and real-time system tracking functions along with with efficient processing and archiving of system data and patient data. System 350 software also interacts with peripheral components such as Ethernet LAN, USB, and AV components, or via a network interface card 338 to implement a system user / machine interface and exchange data with external workstations and data warehouses such as electronic medical records (EMC), electronic medical care cards (ESCs), hospital information systems (LIS), radiological information systems (RIS) and transmission systems and image archiving (PACS), using the DICOM standard for generating and transmitting images, as well as the HL7 (“seventh level”) protocols for transmitting and structuring data.

[0041] The system 350 may also include storage media 304 and 305, such as solid state drives, hard disk drives, and the like. The storage medium 304 may be a storage of system data, which may contain an operating system, main system software, software and an archive of system data and parameters. The storage medium 305 may be a patient data repository 305 that stores all patient data and records.

[0042] The system 350 may include a main module that accommodates or otherwise provides for the presence of various components of the system 350, including user interfaces. The main module may comprise a main module display device 320, such as a liquid crystal display, and a main module device 323 for indicating and user input, such as a terminal or a mouse-type pointing device. The system 350 may also include a remote console 319, which can be used to remotely control the system 350 so that the user does not need to be present during radiotherapy treatment. The device 323 of the main module for indication and user input provides the user with the opportunity to interact with the system 350. The device 323 of the main module for indication and user input can be used for initial installation of patient data in the system 350 and for constructing, using ultrasound, the image of the patient’s tumor at various stages diseases before the period of superficial radiotherapy, during and after it. In addition, the main module device 323 for display and user input can also be a terminal for system 350 software. Images and diagnostic results, patient data, topology of remote workstations, patient and room tracking data, system service menu, system physical and calibration menus and all system requests and alarms can be displayed on the display unit 320 of the main module or through the device 323 of the main module for indication and use Custom input, as appropriate.

[0043] The system 350 may also include an ultrasound device 322 with a transducer 300. The specified ultrasound device can receive images of the treatment area or the examined affected area of the skin. Using an ultrasound device 322 with a transducer 300, a cancer region can be diagnosed. The ultrasonic device 322 may be any ultrasonic device configured to operate on a suitable frequency band. For example, a high frequency ultrasonic device 322 may operate in a frequency band from about 20 MHz to about 70 MHz, and may also be implemented comprising an electromechanical or solid state transducer. The system 350 may include an ultrasound imaging device 322, at least partially integrated into the system case 350 and connected to the bus 310 via a transducer head outside the specified case, as shown in FIG. 2. The imaging device 322 and other components of the system 350 may be in communication with the bus 310 and corresponding other components of the system 350 using interface standards such as peripheral component interconnection (PCI / PCIe), universal serial bus (USB / USBII / USBIII) or Firewire ultrafast data bus.

[0044] The system 350 may further comprise a radiotherapeutic device 326, which contains an x-ray 327. As discussed herein, a radiotherapeutic device 326, containing an x-ray tube 327, can provide targeted radiation therapy to a specific area or area of a patient's body. The radiotherapeutic device 326 may be coupled to a high voltage generator 311 and a central cooling component 316.

[0045] The system 350 may also comprise a control component, such as surface radiation therapy control component 308, in order to control the radiation therapy provided by the radiotherapy device 326. Surface radiation therapy control component 308 can control radiation dosage aspects, including timing, depth, and intensity . Meanwhile, the barbell control component 324 in communication with the surface radiotherapy control component 308 and / or the processor 330 may also be provided in the system 350. The bar control component 324 can move, rotate, or otherwise control the position of the bar on which the radiotherapy device 326 is mounted and x-ray tube 327. To ensure local or remote emergency termination of functions, a main emergency shutdown button 306 may also be provided and removed an emergency shutdown button 307 such that the radiotherapy device 326 can be stopped locally or remotely.

[0046] Additionally, a solid-state beam-sensing component 314 with a solid-state beam sensor 315 may be provided. In one embodiment, these components may be enclosed within the body of the X-ray tube 327. The solid-state reading beam component 314 with the solid-state beam sensor 315 enables on-demand and local analysis of the radiotherapy device 326 with the X-ray tube 327. Using the solid-state reading beam, component 314 with the solid-state sensor 315 beam, radiotherapy device 326 with x-ray tube 327 can be tested to determine if radiation the stroke corresponds to the required radiation output. In the event of a discrepancy, these devices may be re-calibrated or otherwise serviced.

[0047] A central diagnostic component 312 may also be provided that can communicate with the bus 310 and processor 330. The central diagnostic element 312 is also connected to the central connection 313 of the connection test point and further interacts with the signal interface circuit board 309, which in turn is connected to processor 330 via bus 310 and with component 308 for controlling surface radiotherapy. The signal interface circuit board 309 may also include first and second time counters for calculating excess time during the application of radiation therapy, which provides additional safety for the patient and an accurate dosage calculation to provide the patient with a therapeutic dose. In addition to a dual hardware time counter, system 350 can use or run at least one additional software-based time counter.

[0048] The central diagnostic module 312 is a system diagnostic component that monitors various motherboards and components for failures and / or errors. The central diagnostic module 312 may generate an alarm regarding system status, which may be reported to either the user or the system installer or manufacturer for maintenance.

[0049] Additional input devices via bus 310 may be connected to the processor 330, comprising a camera and / or microphone 317, an audio output component 325, such as speakers, a room camera 318 for acquiring patient images or videos, treatment areas, and / or a treatment process. Also, in the event that environmental conditions may affect the treatment or any of the components of the system 350, a humidity and environmental sensor 321 may be provided. However, in this regard, the configuration is not limited.

[0050] FIG. 400 shows imaging with an ultrasound device 400 along with processing, building a three-dimensional tumor model, and analysis method and process 450. As an example, the method and process 450 can be used with systems 150, 250, and 350 and their software, which can be integrated with various system components or can be in operational communication with them, as shown in FIG. 1-3.

[0051] FIG. 4A, the ultrasound head or device 400 comprises an ultrasound transducer 401 located in the head 400. Imaging uses high-frequency ultrasound, which provides a much cleaner image than low-frequency ultrasound, but which does not penetrate deep into the skin. High frequency ultrasound may comprise frequency ranges from about 20 MHz to about 70 MHz, such as from about 35 MHz to about 55 MHz.

[0052] In operation, the method and process 450 may begin with obtaining image data generated by ultrasound. The ultrasound beam 402 is directed to the investigated area, such as the affected area 403, through the epidermis 404, dermis 405 and subcutaneous fat 406. In operation, the transducer 401 sends high-frequency ultrasound waves towards the epidermis 404, dermis 405 and subcutaneous tissue 406, where the tumor is located 403 at various depths, with different contour lengths and volumes. The reflected ultrasound waves 402, which contain data on the physical characteristics of the tumor, receives the transducer 401, as shown in step 412. As an example, the affected area 403 of non-melanoma cancerous skin pathology is located, as shown, while the affected area 403 may extend from the epidermis 404 and inside subcutaneous fat 406.

[0053] Data and images obtained with the ultrasound device 400 are collected by the component 407 for collecting image data and pre-processed in step 413 for further processing, as shown by the flowchart in FIG. 4A. The image data acquisition component 407 may be in operational communication with a central processor 408 that processes the raw data captured by the image data acquisition component 407. At step 409, the central processor 408 may execute software instructions for processing said data to create and construct two-dimensional (2D) images that are layer-by-layer collected over an area imaged by the ultrasound device 400, as shown in step 414.

[0054] In step 410, two-dimensional image layers are processed to construct at least one three-dimensional (3D) image of the volume that the tumor may contain. Also at step 410, a 3D volumetric representation of the tumor can be created, the volume and depth of the tumor can be calculated, and the edges of the tumor can be determined. For example, at step 410, the system can capture each constructed 2D image layer 414 that contains cross-sectional tumor data and process the image. Said treatment may comprise determining the edge of the tumor on each 2D layer. Then, the tumor image for the processed layer 414 2D image can be separated and stored in the corresponding sequential cell in the storage device. This processing may continue until some of the layers of 2D images or all of these layers are processed to obtain a tumor image for each processed layer of a 2D image layer 414, separated and stored in a corresponding sequential cell in a storage device. The system can then combine the plurality of indicated tumor images for each processed layer of a 2D image layer 414, separated and stored in a corresponding sequential cell in a storage device, into a three-dimensional stack, shown in step 415.

[0055] At step 410, a 3D tumor model or volumetric model 416 can be built. The 3D engine for constructing and “rendering” 3D models can combine all or part of the extracted 2D tumor layers, as shown in step 415, sequentially along with their respective thicknesses a layer for combining and merging them into an integrated 3D model that represents and clearly depicts the 3D anatomy and volume of the specified tumor. During construction and construction, the specified 3D engine can apply geometric corrections, smoothing and anatomical triangulation in relation to the constructed 3D model of the tumor in order to successfully perform correlation with the actually scanned or depicted tumor.

[0056] In step 4113D, model 416 may be transmitted to a therapeutic module, which may be hardware or software, for tumor analysis and treatment planning. The therapeutic module 411 can analyze the 3D topography of the tumor and calculate the area of the vesicles of the prescribed treatment along with the appropriate dosimetry to be applied using the radiotherapy device. Dosimetry may contain measurements and calculations of the dose absorbed in the tissue due to exposure to radiation. In one example, the appropriate treatment volume may be spherical, as shown in step 416. Alternatively, the appropriate treatment volume may be any suitable shape that leaves an adequate therapeutic supply around the tumor. The accuracy provided by ultrasound imaging provides a healing margin of about 10%, which is a significant improvement over the conventional healing margin of 300% used in Mos surgery.

[0057] In step 411, the appropriate therapy can be determined using the data and images of step 410. The therapeutic software may contain vector tables identifying the appropriate radiotherapeutic dosage for tumors of various sizes. An example of such a table is provided in FIG. 4B. This provides the system with the ability to accurately calculate therapy parameters containing a therapeutic dosage based on the actual size of the tumor, containing its depth and volume, rather than relying on a doctor who must evaluate the size and depth of the tumor based on experience and the visible surface area of the tumor.

[0058] One embodiment of a method 550 for diagnosis, treatment planning, radiotherapy treatment, post-treatment diagnosis, and reliability confirmation and treatment analysis are provided in the flow chart of FIG. 5. Although the flowchart depicts the steps in some sequence, these steps may be completed in a different logical order, and some steps or groups of steps may be repeated as necessary.

[0059] The method 550 may begin during the pre-treatment imaging step of step 500 with capturing an ultrasound image of the skin. At step 500, the collection of ultrasound images of the study area, such as the affected area of non-melanoma cancerous skin pathology (NMSC), is used to obtain physiological parameters of the indicated affected area or tumor. Then, the collected data and images are transmitted in a processing and imaging step 501. As noted above with respect to FIG. 4A and related discussion, the raw data is the subject of image processing and imaging in step 501. In step 501, the affected area or tumor is evaluated, quantified, and diagnosed, including classification of the type of skin cancer. Pre-treatment imaging is provided by a user, such as a doctor or clinician, using local means for diagnosing a type of skin cancer instead of using a time-consuming and invasive biopsy method. Pre-treatment imaging also provides the user and patient with the opportunity to choose the treatment path for the diagnosed type of skin cancer.

[0060] Based on the original image and analysis data containing any classification such as skin cancer, the clinician and the patient may decide to start surface radiotherapy to treat the affected area of the diagnosed skin cancer pathology. During the disease assessment and treatment planning step, a tumor analysis and quantification step 502 may be performed. The tumor can be analyzed using a 3D engine that processes all the collected 2D sectional images, outlines the tumor anatomy on the 2D image layers and detects the edge of the tumor on each processed 2D layer. Said processing allows the extraction and separate use of the tumor for its respective number / sequence of layers during the reconstruction of the 3D model and the process of quantifying the tumor volume, as shown in steps 415 and 416 of FIG. 4A. Thus, this step may include creating a 3D representation of the tumor and analyzing the appropriate volume of treatment, as described above with respect to steps 415 and 416.

[0061] When a volumetric model of a tumor, such as volumetric model of a tumor 416, is reconstructed, constructed, and quantified, at 503 a treatment plan and dosimetry calculation can be performed. Treatment planning and dosimetric calculations are performed at step 503, when the data and images obtained at step 502 can be further processed and analyzed, including analysis of the tumor and therapeutic factors. The treatment planning may include not only dosimetric calculations (as described above for therapeutic module 411), but also planning the best position on the skin to achieve the center of the tumor and the best angle of the therapeutic head. For treatment planning, the 3D tumor can be oriented according to the anatomy of the area to be treated. Physiological, topographic, and radiotherapeutic dosimetry parameters can be used to calculate and design a treatment plan, target and direct the beam, including the voxel of the area to be treated. A conventional treatment regimen and positioning of the treatment head may also be determined. The treatment plan can be completed and loaded into the patient’s medical record and schedule.

[0062] At 504, a portion of the visual control radiotherapy treatment may be provided. A radiotherapeutic component or device, such as component 220 in FIG. 2 or device 326 in FIG. 3, can be used to provide treatment in accordance with the treatment plan. Thus, the treatment plan can be read and interpreted, and x-ray therapy can be appropriately carried out in relation to the intended affected area. In this case, the X-ray beam therapy is controlled using the obtained 3D images and dosimetric data based on the treatment plan, which was created specifically for the specified patient and the specific affected area of the skin to be treated.

[0063] In one configuration, system components 250 in FIG. 2 can be used to provide radiotherapeutic treatment with visual monitoring of step 504. The treatment head 206 and treatment applicators 307, 308 can be located above the area of the patient to be treated using the integrated video laser positioning system 215, 217. The video laser positioning system works to combine the video image of the treatment area with the low-transparency snapshot of the previous position of the therapeutic head 206 using a crosshair designed by the laser 217 both in real time and in images of previous snapshots. The system then ensures that the video image of the treatment area with the laser crosshair and the snapshot of low transparency with the laser crosshair are aligned in the exact same position, which ensures accurate and reproducible positioning of the therapeutic head 206 over the treated affected area. Once the therapeutic head 206 is in place, the user uses the system 250 to deliver part of the treatment to the affected area. The temporal regime, energy, and beam geometry are controlled by image analysis, 3D tumor modeling, and derivatives of physical and dosimetric calculations and analysis.

[0064] For example, treatment can be provided in the form of multiple treatment sessions, divided into short parts. Each treatment part or session may be less than one minute long, while it provides a dose of about 300 cGy to about 500 cGy per part. Depending on the prescribed total dose, the affected area can be treated with at least one part, such as from about 12 to about 30 parts. Can use more or less shares.

[0065] The treatment series may contain about 5-10 parts per physician protocol prescribed for the conditions and condition of a particular affected area, such as a first stage of cancer (T1), a second stage (T2), and the like. Once the affected area is identified and identified, the periphery of the treatment area is determined. Such periphery, in turn, may determine the diameter of the applicator (such as applicators 207, 208 in FIG. 2) that can be used. Typically, the selected applicator for treating a particular periphery of the affected area may be at least 20% larger in area and / or diameter than the affected area to be treated. The clinician can create a specialized master template that will be cut to match the size and shape of the affected area with an approximate 15% margin in order to ensure that an entire x-ray is applied to the x-ray beam. All healthy cells that will be irradiated with an X-ray beam usually recover successfully and return to normal, while malignant cells pass through apoptosis, after which they do not recover.

[0066] The specified template can be placed over the affected area with a hole cut out in the center of the treated area, and the selected applicator will be fixed on the head of the x-ray tube. The treatment system can be set to the appropriate energy level and treatment time period (for example, approximately 20-40 seconds), which is set by vector tables for the conditions of each specific affected area and the separation scheme. The clinician can set the head of the x-ray tube in a position opposite the applicator and can activate the system using a remote console located outside the treatment room. The system can provide the selected energy for a set time and can stop the treatment as soon as the time counters are counted to zero. The patient can be released and called for the next scheduled session or part of the treatment.

[0067] As will be discussed below, step 504 of the radiotherapy treatment with visual control can be repeated, but can also be reviewed if necessary. For example, during the course of treatment, the depth, width or full size of the tumor of an irregular shape may decrease. Retreatment can be reduced in relation to the size of the treatment area or the intensity of the treatment so that only the necessary amount of radiation is applied to such a small area as necessary.

[0068] Then, the method 500 enters the post-treatment imaging phase. The post-treatment imaging phase may be a repeating imaging procedure for the affected area, which is completed after preliminary imaging and evaluation of the affected area. Post-treatment imaging provides the ability to track and evaluate the therapeutic development and progress of healing of the affected area under treatment during a divided therapeutic process. The imaging interval of the affected area is determined by the clinician in accordance with the protocol illustrated in FIG. 7 and discussed below.

[0069] In step 505, the image of the treatment area can be re-formed using an ultrasound device, such as the ultrasonic device 400 in FIG. 4A. During step 505, the actions and operations of step 500 may be repeated; thus, step 505 may include an ultrasound scan of the treatment site after the first and subsequent parts of the therapy to accumulate timely images and data about the treatment area.

[0070] Post-treatment images and data about the area to be treated can be processed, and additional images can be visually constructed at step 506. During step 506, the actions and operations of step 501 can be repeated.

[0071] Method 550 may proceed to verify treatment efficacy and analyze steps 507 and 508, which reanalyze the topography and volume of the affected area over time throughout the treatment time period and after treatment is completed during subsequent sessions. At step 507, post-treatment images and data from steps 505 and 506 can be evaluated to determine how the affected area responds to therapy compared to the expected cure rate in accordance with the prescribed dosimetry and division scheme into part of the treatment plan. Step 507 may include at least one action or operation of step 502 to fully analyze the tumor or affected area.

[0072] As an example, if recently collected images and data indicate immunity, the treatment plan or other factors may be reviewed. In this case, step 503 can be repeated, since the treatment plan can be changed based on post-treatment imaging and evaluation. On the other hand, if recently acquired images and data indicate susceptibility, then the treatment plan can be confirmed, and the treatment can move forward. These steps provide a continuous assessment of the affected area being treated during treatment and upon completion in order to evaluate the change in the affected area and its response to therapy. Post-treatment analysis can also be during post-treatment follow-up sessions of the patient in order to document and certify or confirm the complete recovery or cure of the affected area of skin cancer pathology in the treated area.

[0073] At 508, validation and confirmation of the effectiveness of the therapy can be obtained. Step 508 may include triangulating images depending on time and volume. By triangulating 2D or 3D images, you can track the size and shape of a tumor or affected area. In addition, a volumetric analysis of the tumor over time can also be performed. Changes in the size, shape and volume of the tumor can be compared again to determine the effectiveness of the treatment, at the same time taking into account the parameters of the conversion of the tumor and its response to therapy. Thus, the clinician receives a continuous accurate assessment of the patient's response to therapy and can adjust this therapy, if necessary, in order to further optimize the outcome of the disease for the patient. For example, the length or intensity of treatment sessions may be reduced or increased. Step 508 can be completed locally by the clinician in a non-aggressive manner without any discomfort for the patient or the need for additional laboratory and pathological services.

[0074] At step 509, the patient’s medical record can be saved and method 550 completed. A medical record may contain data and images related to the patient’s medical history, results and summary reports that illustrate the patient’s disease status from the start of the procedure to the final conclusion. Medical records can be stored locally or in online card stores.

[0075] If necessary, any of these steps may be repeated. For example, a tumor may require several treatment sessions before treatment is complete. The imaging steps, planning and evaluation steps, and treatment steps can be repeated many times.

[0076] Since all of these steps can be performed using a single machine in a general practitioner’s office, this significantly reduces the time, inconvenience, and expense associated with diagnosing and treating non-melanoma skin cancer. Additionally, since this reduces or eliminates the need for Mos surgery, the patient’s subsequent healing time and scarring are significantly reduced.

[0077] Referring to FIG. 6: a solid-state beam sensor and a beam-sensing component 650 may be provided, such as a solid-state beam sensor 313 and a beam-reading component 312 of FIG. 3, or the solid-state x-ray beam reading component 102 of FIG. 1. These components may be enclosed in an x-ray tube housing 611, such as an x-ray tube in the therapy head 206 in FIG. 2.

[0078] Component or device 650 may include a retractable support structure 603, 604, which can also be enclosed in an X-ray tube housing 611. An X-ray imaging matrix detector may also be provided, such as an array of solid-state X-ray detectors 602, which is located between the X-ray tube 600 with the alignment 601 of the X-ray tube and the radiation stiffening aluminum brake filter 607. An array of solid state x-ray detectors 602 that is mounted on a retractable support structure 603 can be used to read the output of the x-ray beam 612 from the x-ray tube 600.

[0079] A retractable support structure 603 can move the solid state detector array 602 between the x-ray test position, as shown in FIG. 4A, and the provision for the lack of testing. In the non-testing position, the solid state detector matrix 602 and the extendable support structure 603 are retracted or moved away from the emitted x-ray region so that they do not absorb, block, or otherwise affect the radiation emitted by the x-ray tube 600.

[0080] When an X-ray beam 612 is detected, the solid-state detector matrix 602 can read the characteristics of the radiation emitted by the X-ray tube 600. The detector matrix 602 can be used to generate a matrix-detailed image of the periphery of the X-ray beam 612 along with the intensity of the X-ray particle particles.

[0081] The X-ray imaging matrix detector may be a single-line array of solid state x-ray detectors that receives and accumulates beam characteristics during a verification or testing procedure. One characteristic is the integrity of the beam shape, which confirms that the output of the x-ray tube is actually homogeneous and free of defects. Another characteristic is the beam intensity, which can be measured in the following units: centigray (cGy) and kilovolt (kV). Other characteristics read by the X-ray imaging matrix detector comprise a section or a beam shape. An X-ray image array matrix detector can also accurately measure the photons emitted by the X-ray tube 600. Additionally, an X-ray image array matrix detector can also be used to determine if the X-ray tube window 601 is correctly aligned or if alignment is required.

[0082] The collected data may be transmitted to the beam-reading component, such as the beam-reading component 312 in FIG. 3, which preprocesses this data. Pre-processed data can be transferred to a processor, such as processor 330, for further analysis and visualization. A solid-state beam sensor and a beam-sensing component can be used as a tool for daily quality control and for system diagnostics. For example, a solid-state beam detector and a beam-sensing component can detect the difference between the programmed radiation and the output of the X-ray tube 600. Detection may provide maintenance capabilities to ensure that the required dosage of treatment is provided. Additionally, testing can be automated prior to use such that the emitted x-ray and / or alignment of the x-ray tube window 601 is confirmed before each use.

[0083] The retractable support structure 603, 604 may comprise at least one motor or actuator 613 and positioning components 605, 606. The motor or actuator 613 may be controlled by a processor, such as processor 330, using a beam-sensing component 314. Motor or actuator 613 can move the solid state detector array 602 between the X-ray test position and the non-test position.

[0084] FIG. 6 also shows a removable therapeutic head 609 with a tip 610, which can be replaced to match the treatment area and the desired depth. Suitable therapeutic heads that can be used in component 650 may include therapeutic applicators having a head diameter in the range of from about 1 cm to about 7.3 cm, from a source to skin distance of about 15 cm, and also in the range of about 1 cm up to approximately 12.7 cm with a distance from the source to the skin of approximately 25 cm. A removable head 609 can be used with the radiotherapeutic device 220 and 326.

[0085] FIG. 7 is a flowchart of a control protocol for a 750 patient and treatment. When the patient first arrives at the doctor or clinician, step 700 of receiving and advising the patient is performed. At this point, the patient is enrolled in a practical workflow management system that can be integrated with a visual inspection hybrid surface radiotherapy system that can use protocols such as the DICOM and HL7 protocols such as the 350 system illustrated in FIG. 3 or any suitable system.

[0086] Upon registration, the patient may be assigned a schedule of initial prognosis and consultation with the clinician. During the initial prognosis and consultation, the patient can be scanned by means of an ultrasound device as part of the visual inspection phase 707. The scan provides the clinician and patient with an assessment of any affected area and condition of the disease before deciding on the recommended and preferred route of treatment. Then, visual data about the scanned affected area is processed and reconstructed at step 702 to construct 2D image layers of the scanned area that contain a 2D section of the tumor. If required, these images can be viewed. The indicated 2D tumor data can also be converted into a 3D volumetric model and visualized to obtain all volumetric and physiological tumor data from the scanned affected area, for use in the following steps.

[0087] The treatment planning step 703 uses the quantified data to calculate and generate a personalized treatment plan for this patient and the affected area to be treated.

[0088] Then, therapy can begin at step 704, and imaging is still applied at step 708 at various intervals in accordance with the clinician's protocol and treatment plan to track and control the course of therapy throughout the prescribed parts of the treatment and the entire treatment time frame.

[0089] In order to confirm and track the complete recovery of the treated affected area, repeat sessions 705 for the patient can be performed. As an example, repeated sessions can be performed months or years after the last therapy session to track the area of the treated affected area. This stage is also carried out with visual inspection 709 using images obtained by means of a high-frequency ultrasound device in order to add additional confirmation to the treatment result and to verify that the affected area is certainly completely cured.

[0090] Although the entire therapeutic sequence is completed at step 706, the patient data and the corresponding visual control data are archived and submitted to medical records and healthcare management systems. Thanks to the complete treatment process, including non-invasive imaging as a substitute for an invasive, time-consuming and expensive biopsy, which significantly improves and improves the patient care procedure, providing a beneficial effect for all interested parties, including the patient, the clinician and the healthcare system as a whole ..

[0091] FIG. 8F and 8B depict two examples of imaging at a frequency of 40 MHz, with FIG. 8A, no skin cancer was detected, and in FIG. 8B, three possible regions of cancerous tissue are shown below the surface of the epidermis. These images are examples of images that can be obtained before and after treatment. They show that cancerous tissue can be of uneven shape, full size, depth and width. Given these sizes and shapes, accurate radiotherapy treatment can be provided.

[0092] These systems, methods and devices include widespread use outside the treatment of affected areas or skin cancer. For example, these systems, methods and devices can be used as internal operating radiotherapy in a surgical environment for the treatment of other types of cancer or affected areas when the corresponding tumors are surgically removed. In addition to removing the tumor, using the systems, methods and devices described herein, it is possible to visualize, analyze and treat a dissected area, such as an excised area with at least one part of the treatment of 21 cGy before suturing the patient.

[0093] These systems, methods and devices provide many advantages and improvements for the treatment of skin cancer. In particular, an implementation in which high-frequency ultrasound can be used to accurately visualize the affected area of the skin, as well as to plan treatment, provides a much more accurate treatment. In addition, this provides the possibility of a much more accurate and technically advanced application of surface radiotherapy than was previously possible, and also reduces or eliminates the need for Mos surgery. Finally, accurate visualization and construction of a three-dimensional model of tumors means that the therapist no longer needs to biopsy suspicious affected areas.

[0094] In some system configurations, methods and protocols can be used for relatively shallow tumors that are not skin cancer, such as some breast cancer, in which case the therapeutic head may contain a surgical catheter for insertion under the skin along with a small-sized spherical therapeutic head .

[0095] It is important to note that the methods described above may include any functionality, devices, and / or features of the systems described above, or in other cases, are not intended to be limited by the description or examples presented herein.

[0096] Turning now to FIG. 9, at least a portion of the techniques and technologies described in relation to exemplary embodiments of the invention may comprise a machine, such as, but not limited to, a computer system 900 or other computer device that contains a set of instructions that, when executed, may cause the machine to execute any at least one technique or function described above. Said machine may be configured to simplify various operations conducted by the systems shown in FIG. 3 and 4. For example, a machine may be configured to, inter alia, provide assistance to these systems by providing processing power to assist in processing performed by the systems, by providing a memory capacity for storing instructions or data moving in the system, or by assisting in any other operations conducted by or in these systems.

[0097] In some embodiments of the invention, the specified machine operates as a stand-alone device. In some embodiments, a machine may be connected (for example, using a network 935) via a network interface, such as network interface 328, to assist in operations performed by other machines, such as, among others, radiotherapy device 326, central diagnostic component 312, storage 304 and 305 of data, component 308 for controlling surface radiotherapy, or other devices or components of the system of FIG. 3, including combinations thereof. The machine may be connected to any system components in FIG. 3. In a network location, a machine can operate as a server or a client user machine in a server-to-client network environment, or as a peer machine in a peer-to-peer (or distributed) network environment. A machine may comprise a server computer, a client user computer, a personal computer (PC), a tablet PC, a laptop computer, a desktop computer, a network router, a switch or a bridge, or any machine configured to execute a set of instructions (sequentially or otherwise) that determine the actions to be performed by this machine. Additionally, although one machine is depicted, the term “machine” should also be taken to include any group of machines that separately or collectively execute a set (or multiple sets) of instructions to perform any of the at least one technique discussed herein.

[0098] The computer system 900 may include a processor 902 (eg, a central processing unit (CPU), a graphics processor (GPU), or both), a main storage device 904, and a static storage device 906 that communicate with each other via a bus 908. A computer system 900 may further comprise a video display module 910 (e.g., a liquid crystal (LCD) display, a flat panel, a solid state display, or a cathode ray tube (CRT)). The computer system 900 may include an input device 912 (e.g., a keyboard), a cursor control device (e.g., a mouse), a disk drive 916, a signal generation device (e.g., speakers or remote control) 918, and a network interface device 920.

[0099] The disk drive 916 may comprise a computer-readable medium 922 that stores at least one set of instructions 924 (eg, software) using at least one technique or function described herein, including the methods shown above. Instructions 924 may also reside, in whole or at least partially, in main memory 904, static memory 906, or in processor 902 or a combination thereof, during execution by computer system 900. Main memory 904 and processor 902 may also represent are machine-readable media.

[00100] Implementations of specialized hardware, including but not limited to specialized integrated circuits, programmable logic arrays, and other hardware devices, can likewise be constructed to implement the methods described herein. Applications that may include devices and systems of various embodiments broadly comprise a variety of electronic and computer systems. Some embodiments implement functions in at least two special interconnected hardware modules or devices with appropriate control and exchange of data signals between these modules, or as parts of specialized integrated circuits. Thus, an exemplary system is applicable in software, hardware, and software / hardware implementations.

[00101] In accordance with various embodiments of the present invention, the methods described herein are intended to operate as computer programs running on a computer processor. In addition, software implementations may include, among other things, distributed processing or distributed processing of a component / object, parallel processing, or a virtual processing machine may also be designed to implement the methods described herein.

[00102] The present invention provides a computer-readable medium 922 comprising instructions 924 such that a device connected to a communication network 935 can send or receive voice data, video images and data, as well as communicate via a network 935 using these instructions. Instructions 924 may additionally be transmitted or received over the network 935 via the network interface device 1320.

[00103] Although the computer-readable medium 1322 is shown in the exemplary embodiment as a single medium, the term “computer-readable medium” should be understood to comprise one medium or multiple media (for example, a centralized or distributed database and / or associated buffer memory and server) that store at least one set of instructions. The term "computer-readable medium" should also be understood as comprising any information medium that is configured to store, encode or carry a set of instructions for execution by a machine, and which cause the machine to perform any at least one technique of the present invention.

[00104] The term “machine-readable medium” should accordingly be understood to include, among other things: solid-state storage devices, such as memory cards or other shells, which contain at least one read-only (non-volatile) memory device, random access memory device, or rewritable device (volatile) storage device, magneto-optical or optical media such as a disk or tape, or other information-containing archive or set of archives are considered as the equivalent of a distributed storage medium for a tangible storage medium. In one embodiment of the invention, the computer-readable storage medium may be a computer-readable storage device or a computer-readable device. Therefore, it is intended that the present invention comprise any at least one computer-readable storage medium or a distributable storage medium as listed herein, and contains recognized prior art equivalents and subsequent storage media that store the software implementations set forth herein.

[00105] The configuration illustrations described herein are intended to provide a general understanding of the structure of various embodiments of the invention, and are not intended to serve as a complete description of the elements and features of devices and systems that can use the structures described herein. When viewing the above description, those skilled in the art will understand many other configurations. Other configurations can be used, and also obtained on their basis, so that without departing from the essence of the present invention, structural and logical substitutions and changes can be made. The drawings are also representative and may not be drawn to scale. Some of their proportions may be exaggerated, while others may be minimized. Therefore, the specification and drawings are to be regarded as illustrative and not restrictive.

[00106] Thus, although specific configurations have been described and shown herein, it should be understood that the specific configurations shown can be replaced with any configurations designed to achieve the same objectives. The present invention is intended to cover any or all modifications and changes of various embodiments and configurations of the present invention. When viewing the above description, those skilled in the art will understand combinations of the above configurations, as well as other configurations. Therefore, it is contemplated that the present invention is not limited to the specific configurations disclosed as the best option contemplated for carrying out the present invention, but that the present invention will include all embodiments and configurations that are within the scope of the appended claims.

[00107] The foregoing is provided for purposes of illustrating, explaining and describing embodiments of the present invention. Modifications and changes to these embodiments will be apparent to those skilled in the art and may be made without departing from the scope of the present invention or its essence. When viewing the aforementioned embodiments, it will be apparent to those skilled in the art that these embodiments can be modified, reduced, or improved without departing from the scope of the claims described below.

Claims (68)

1. A system for radiation treatment of affected areas of the skin, containing: a small-sized movable main module containing at least one processor for collecting and processing data used in planning and conducting radiation treatment; a high-frequency ultrasound imaging device connected by a wire to the main module, a high-frequency ultrasonic device is configured to scan and collect image data related to the anatomy and topology of the skin of the patient, and message image data to the specified at least one processor, and the high-frequency ultrasonic device is arranged work at an ultrasonic frequency in the range from 20 to 70 MHz to obtain images of the affected area, I am present boiling inside at one of a plurality of layers of the skin selected from the group consisting of epidermis, dermis and subcutaneous layer; wherein said at least one processor is configured to execute instructions stored in a storage device for performing operations including: receiving a plurality of layers of two-dimensional images from a high-frequency ultrasonic imaging device, wherein each image layer passes through said plurality of skin layers; separating the affected area within the skin layers, including the edges of the affected area, in each of the plurality of layers of two-dimensional images to obtain a plurality of processed image layers; combining at least a portion of the plurality of processed layers of two-dimensional images to construct a three-dimensional model of the affected area, including parts below the surface of the affected area and edges below the surface of the affected area within the plurality of skin layers; analysis of a three-dimensional model of the affected area within a plurality of skin layers to determine the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area; determining therapeutic dosimetry based on at least the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area, the therapeutic dosimetry parameters including energy level, dose location and three-dimensional dose boundaries defined within multiple layers of the skin; a radiotherapeutic device mounted on a small-sized movable main module and configured to operate under the control of said at least one processor, the radiotherapeutic device comprising a therapeutic rod and a therapeutic head, wherein the therapeutic rod is hinged to facilitate positioning of the therapeutic head at the site of radiotherapy treatment of the affected areas based on the indicated therapeutic dosimetry, while ter the singing head is configured to provide, at the command of said at least one processor, radiotherapy treatment in accordance with the energy level, dose location and three-dimensional dose limits specified by therapeutic dosimetry, the radiotherapy treatment including emitting an x-ray beam, the x-ray beam being in the form of an initial beam when emitted from a therapeutic head; at least one positioning system configured to obtain positioning and alignment data of the therapeutic head in accordance with the dose location and three-dimensional dose boundaries for the affected area, the processor storing the positioning data and outputting positioning data so as to allow adjustment of the therapeutic head to be reproduced in subsequent treatments. 2. The system of claim 1, further comprising: a camera located on the specified hinge rod; a laser pointer located on the specified radiotherapy device; moreover, the camera and the laser pointer form a video laser positioning system. 3. The system of claim 1, further comprising: an x-ray tube and an array of solid-state x-ray detectors inside a radiotherapy device for reading the characteristics of the radiation emitted by the x-ray tube. 4. The system of claim 3, wherein the operations further include: testing a radiotherapy device using an array of solid state x-ray detectors; characterization of radiation emitted by an x-ray tube based on testing of a radiotherapy device; and adjusting the radiotherapy device based on the characteristics of the radiation emitted by the x-ray tube. 5. The system according to claim 1, further comprising a template made in accordance with therapeutic dosimetry to be placed on top of the affected area to limit the shape of the x-ray beam from the shape of the original beam when emitted from the therapeutic head to a second therapeutic beam shape different from the original beam shape . 6. A system for providing therapeutic dosimetry for use with a radiotherapeutic device for radiation treatment of affected skin regions present within at least one of a plurality of skin layers selected from the group consisting of epidermis, dermis and subcutaneous layers, comprising: a memory device storing instructions; and a processor that executes instructions for performing operations, including: receiving a plurality of layers of two-dimensional images of the affected area from a high-frequency ultrasonic imaging device, wherein each image layer passes through said plurality of skin layers; separating the affected area within the skin layers in each of the plurality of layers of two-dimensional images to obtain a plurality of processed images; combining at least part of the plurality of processed image layers to construct a three-dimensional model of the affected area, including parts below the surface of the affected area and edges below the surface of the affected area within the plurality of skin layers; analysis of a three-dimensional model of the affected area within a plurality of skin layers to determine the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area; determining therapeutic dosimetry based on at least the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area, the therapeutic dosimetry parameters including energy level, dose location and three-dimensional dose boundaries defined within multiple layers of the skin; and providing therapeutic dosimetry for use with a radiotherapy device. 7. The system of claim 6, wherein the operations further include: receiving test data from a radiotherapy device using an array of solid state x-ray detectors; and characterization of radiation emitted by an x-ray tube based on testing of a radiotherapy device. 8. The system of claim 7, wherein the operations further include adjusting the radiotherapy device based on the characteristics of the radiation emitted by the x-ray tube. 9. The system of claim 6, wherein the operations further include: analysis of the volume of the affected area after treatment; and determination of a therapeutic voxel corresponding to the volume of the affected area to be treated. 10. A computer-readable device for a therapeutic dosimetry support system, containing instructions that, when executed by a processor, provide the processor to carry out operations including: receiving multiple layers of two-dimensional images of the affected area of the skin present within at least one of the plurality of skin layers selected from the group consisting of the epidermis, dermis and subcutaneous layers, the image layers being received from a high-frequency ultrasound imaging device, and each image layer passes through the specified many layers of skin; separating the affected area within the skin layers in each of the plurality of layers of two-dimensional images to obtain a plurality of processed images; combining at least a portion of the plurality of processed layers of two-dimensional images to construct a three-dimensional model of the affected area, including parts below the surface of the affected area and edges below the surface of the affected area within the plurality of skin layers; analysis of a three-dimensional model of the affected area within a plurality of skin layers to determine the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area; determining therapeutic dosimetry based on at least the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area, the therapeutic dosimetry parameters including energy level, dose location and three-dimensional dose boundaries defined within multiple layers of the skin; and providing therapeutic dosimetry for use with a radiotherapy device. 11. A computer-readable device according to claim 10, in which the operations further include: receiving test data from a radiotherapy device using an array of solid state x-ray detectors; and characterization of radiation emitted by an x-ray tube based on test data from a radiotherapy device. 12. A computer-readable device according to claim 11, in which the operations further include adjusting the radiotherapy device based on the characteristics of the radiation emitted by the x-ray tube. 13. A computer-readable device according to claim 10, wherein the operations further include determining a therapeutic voxel corresponding to the volume of the affected area to be treated. 14. A method of treating an affected area of the skin, comprising: obtaining multiple layers of two-dimensional images of the affected area of the skin present within at least one of the many skin layers selected from the group consisting of the epidermis, dermis and subcutaneous layers, the image layers being obtained by means of a high-frequency ultrasound device, and each image layer passes through the specified many layers skin through a high-frequency ultrasound device; processing through the use of instructions stored in the storage device and executed by the processor, a plurality of layers of two-dimensional images to separate the affected area within the skin layers and obtain a plurality of processed images; combining at least a portion of the plurality of processed layers of two-dimensional images to construct a three-dimensional model of the affected area, including parts below the surface of the affected area and edges below the surface of the affected area within the plurality of skin layers; analysis of a three-dimensional model of the affected area within a plurality of skin layers to determine the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area; determining therapeutic dosimetry based on at least the type of lesion, the volume of the affected area, the edges of the affected area and the depth of the affected area, the therapeutic dosimetry parameters including energy level, dose location and three-dimensional dose boundaries defined within multiple layers of the skin; and providing a targeted radiotherapeutic effect on the affected area based on therapeutic dosimetry, wherein the targeted radiotherapeutic effect includes the step of providing a radiotherapeutic device mounted on a small-sized movable main module and configured to operate under the control of said at least one processor, the radiotherapeutic device comprising a therapeutic rod and therapeutic head, therapeutic rod is made articulated to facilitate the positioning of the therapeutic head at the site of radiotherapeutic treatment of the affected area based on therapeutic dosimetry, while the therapeutic head is configured to provide radiotherapeutic treatment at the command of said at least one processor in accordance with the energy level, dose location and three-dimensional dose limits specified therapeutic dosimetry, and radiotherapy treatment includes the emission of x-ray UČKA, wherein the X-ray beam has an initial beam shape when the emission of the therapeutic head. 15. The method according to p. 14, further providing: obtaining multiple images of the affected area after radiotherapy treatment using a high-frequency ultrasound device after providing the targeted radiotherapeutic effect on this affected area and during the treatment period; providing further targeted radiotherapeutic effects on the affected area based on a plurality of images of the affected area after radiotherapy treatment; and providing at least one positioning system configured to obtain positioning and alignment data of the therapeutic head in accordance with the dose location and three-dimensional dose boundaries for the affected area, the processor saving the positioning data and outputting positioning data so as to allow adjustment of the therapeutic head to be reproduced when subsequent treatments. 16. The method of claim 14, further comprising: providing targeted radiotherapeutic effects on the affected area, including many sessions of providing targeted radiotherapeutic effects on the affected area during the treatment period; analysis of the topography of the affected area periodically during the treatment period. 17. The method according to p. 16, further comprising analyzing the volume of the affected area periodically during the treatment period. 18. The method of claim 14, further comprising determining a therapeutic voxel corresponding to the volume of the affected area to be treated. 19. The method according to p. 14, further comprising the step of providing a template made in accordance with therapeutic dosimetry and placing the specified template on top of the affected area to limit the shape of the x-ray beam from the shape of the original beam when it is emitted from the therapeutic head to the second therapeutic beam shape. 20. The method according to p. 19, in which the template is configured to provide a stock of treatment up to 15% when applying radiation to the affected area.

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